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HIVNCT01203332

Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults

An observational study of HIV, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. Read more about this study

Who is it for?
Ages 13 to 24 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Effectiveness of different strategies in HIV testing and linkage to care
How many people
1,917 participants
Where
13 sitesin 2 countries
Study dates
Jul 2010to Jan 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Adolescent and young adult Hispanic/Latino MSM and heterosexual men and women, aged 13-24 years, who meet all eligibility requirements for enrollment into the AVT or SSNIT component of the study.

  1. Inclusion Criteria

1a. Alternative Venue-Based Testing (AVT) Participants

  • Self-identifies as being of Hispanic or Latino ethnicity;
  • Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
  • Self-reports a negative or unknown HIV status;
  • Is male and self-reports any unprotected anal sex with a male sexual partner in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with two or more male sexual partners in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
  • Willing to complete an HIV risk assessment;
  • Willing to undergo HIV screening; and
  • Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1b. Social and Sexual Index Recruiter Participants
  • Self-identifies as being of Hispanic or Latino ethnicity;
  • Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
  • Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
  • Willing to complete a HIV risk assessment;
  • Willing to undergo HIV screening (or an HIV confirmatory test if previously diagnosed);
  • Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for a Social and Sexual Network Member for participation in the study; and
  • Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1c. Social and Sexual Network Members
  • Self-identifies as being of Hispanic or Latino ethnicity;
  • Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
  • Self-reports any anal or vaginal sexual activity in the past 3 months and any unprotected anal or vaginal sex in the last 12 months; OR Self-reports any history of injection drug use;
  • Willing to complete a HIV risk assessment;
  • Willing to undergo HIV screening; and
  • Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1d. Additional Inclusion Criteria for Social and Sexual Network Member Recruiters
  • Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an IDU in the past 12 months; and
  • Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for Social and Sexual Network Members for participation in the study.
  1. Exclusion Criteria 2a. All Participants
  • Previous participation in ATN 096 as an AVT or a SSNIT study participant;
  • Current or prior participation in ATN 084;
  • Anything that would impair the participant's ability to provide informed consent/assent and/or interfere with the protocol's objectives; i.e., readily apparent psychiatric symptoms (hallucinations, thought disorder), visibly distraught (suicidal, homicidal, exhibiting violent behavior) or visibly intoxicated or under the influence of alcohol or other substances at the time of study enrollment, and
  • Acute illness that, in the opinion of study staff, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives. 2b. Additional Exclusion Criteria for Alternative Venue-Based Testing Participants
  • Self-reports a prior diagnosis of HIV

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States12 sites
  • University of Maryland

    Baltimore, Maryland, 21201

  • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

    Chicago, Illinois, 60612

  • Childrens Diagnostic & Treatment Center

    Fort Lauderdale, Florida, 33316

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • St. Jude Childrens Research Hospital

    Memphis, Tennessee, 38105-2794

  • University of Miami School of Medicine

    Miami, Florida, 33101

  • Mount Sinai Medical Center

    New York, New York, 10128

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco

    San Francisco, California, 94117

  • University of South Florida

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Childrens National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Puerto Rico1 site
  • University of Puerto Rico

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.

Conditions
HIV
Being tested
Effectiveness of different strategies in HIV testing and linkage to care
Keywords
HIV testing, Latino, Latina, Men who have sex with men
Medical subject headings
Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Effectiveness of different strategies in HIV testing and linkage to careBehavioural

    HIV testing Linkage to Care

Study groups in NCT01203332
Study groupRoleWhat they receive
Alternative Venue Testing (AVT)Participants recruited for testing through the AVT recruitment method.
Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care
SSNIT - Index RecruiterParticipants recruited for HIV testing and to bring members of their social and sexual network to the study.
Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care
SSNIT - Network MemberParticipants recruited by someone in their social or sexual network to participate in the study, including HIV testing.
Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of AVT strategy with SSNIT

    To compare the relative effectiveness of AVT with SSNIT, which is a coupon-based index recruiter driven network recruitment strategy for identifying previously undiagnosed HIV infection among Hispanic/Latino adolescents and young adults aged 13-24 years.

    Measured: 2 years

  2. Facilitators & barriers to HIV testing

    To examine factors that facilitate and/or hinder Hispanic/Latino adolescents and young adults in getting an HIV test (e.g., perceived risk for HIV, acculturation, homophobia, stigma associated with IDU).

    Measured: 2 years

  3. Sub-group differences

    To explore the extent to which sub-group differences (e.g., origin of birth, age, level of acculturation) exist by prevalence of HIV-related risk behaviors, HIV testing, and mode of HIV transmission.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,917 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01203332
Sponsor's protocol ID
ATN 096
Status last verified
Mar 2016
First submitted
15 Sep 2010
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of AVT strategy with SSNIT (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.

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